Gastric Cancer
Conditions
Interventions
Experimental group:Eligible subjects who meet the inclusion and exclusion criteria will receive treatment with Cadonilimab (10 mg/kg, i.v., Day 1, every 3 weeks) in combination with the XELOX regimen
Oxaliplatin: 130 mg/m2, i.v., Day 1, every 3 weeks) for 2 to 4 cycles. Within 3 to 4 weeks after the final dose, subjects will undergo preoperative imaging assessments to evaluate treatment efficacy a
Sponsors
The First Affiliated Hospital of Anhui Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Provided written informed consent before performing any trial-related procedures; 2. Age >=18 years old, regardless of gender; 3. Gastric and gastroesophageal junction adenocarcinoma confirmed by histopathological examination; 4. Patients who were initially diagnosed as unresectable according to enhanced CT/PET-CT/MRI scan or other imaging data, namely the first three types of stage IV gastric cancer classified by Yoshida: Type 1 (potentially resectable, including patients with a single liver metastasis, positive or metastatic para-cancer lymph node no.16a2 and/or 16b1), type 2 (borderline resectable, including more than one liver metastasis or a single tumor > 5cm, adjacent vein or portal vein, pulmonary metastasis, or left supraclavicular lymph node metastasis; Patients with 16a2/b1 metastasis) and type 3 (patients with peritoneal metastasis but without distant metastasis, except patients with palliative resection who cannot be cured or resected); 5. No previous systemic treatment for the current disease, including surgical treatment, anti-tumor chemoradiotherapy/immunotherapy, etc. 6. Patients who agree to receive surgical treatment and have no surgical contraindications as judged by the surgeon; 7. At least one radiographic measurable lesion according to response Evaluation Criteria in Solid Tumors (RECIST, version 1.1); 8. ECOG score 0-1; 9. Expected survival time >3 months; 10. Adequate organ function: meeting the following laboratory diagnostic criteria: (blood routine) absolute neutrophil count (ANC) >=1.5×10^9/L; Platelet count (PLT) >=100×10^9/L; Hemoglobin (HGB) >=9.0 g/dL; (Liver function) Patients without liver metastasis were required to have serum total bilirubin (TBIL) =50 mL/min (calculated by Cockcroft/Gault formula); (Coagulation function) 4) adequate coagulation function, defined as INR or PT <=1.5 times ULN; If the subject is receiving anticoagulant therapy, as long as the PT is within the prescribed range of anticoagulant drugs. 11. No medical contraindications seriously affecting anesthesia and surgery; 12. Female subjects of childbearing age or male subjects whose sexual partner is a female of childbearing age are required to use effective contraception during the entire treatment period and for 6 months after the treatment period.
Exclusion criteria
Exclusion criteria: Patients with any of the following were excluded from the study: 1. HER-2 positive patients; 2. Known signs of active bleeding on endoscopy and a history of gastrointestinal perforation and/or fistula within 6 months; 3. Malignant diseases other than gastric cancer (excluding radical skin basal cell carcinoma, skin squamous cell carcinoma, and/or radical resection in situ carcinoma) diagnosed within 5 years before the first dose; 4. Currently participating in an interventional clinical study treatment, or receiving another study drug or using a study device within 4 weeks before the first dose; 5. Active autoimmune disease requiring systemic therapy (e.g., disease-modifying agents, glucocorticoids, or immunosuppressive agents) occurred within 2 years before the first dose. Alternative therapies (e.g., thyroxine, insulin, or physiological glucocorticoids for adrenal or pituitary insufficiency) were not considered systemic therapy; 6. Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation; 7. Patients with known allergies to the drugs used in this study; 8. Has not fully recovered from any intervention-related toxicity and/or complications before starting treatment (i.e., grade <=1 or baseline, excluding fatigue or alopecia); 9. Known history of human immunodeficiency virus (HIV) infection (i.e., HIV 1/2 antibody positive); 10. Untreated active hepatitis B (defined as both HBsAg positivity and HBV-DNA copies greater than the upper limit of normal in the laboratory at the participating center); 11. Active HCV-infected subjects (HCV-antibody positive and HCV-RNA level above the lower limit of detection); 12. A live vaccine dose within 30 days before the first dose (cycle 1, day 1); 13. Pregnant or lactating women; 14. The presence of any serious or uncontrolled systemic illness; 15. Use of immunosuppressive drugs within 4 weeks before the first dose of study treatment, excluding topical glucocorticoids by nasal spray, inhalation, or other route or systemic glucocorticoids at physiological doses (i.e., not more than 10mg per day of prednisone or equivalent doses of other glucocorticoids), or the use of hormones to prevent allergy to contrast media. 16. Medical history or evidence of disease, treatment or laboratory abnormalities, or other conditions deemed by the investigator to be inappropriate for enrollment that may interfere with the results of the trial, prevent the participant from participating in the study fully.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-Free Survival;R0 excision rate; | — |
Countries
China
Contacts
Public ContactYongxiang Li
The First Affiliated Hospital of Anhui Medical University
Outcome results
None listed